I E - CDPH Home Document Libr… · E 483 . T22 DIV5 CH1 ART3-70263(g) Pharmaceutical E 483 : 7. Pharmacists will now mix all Dilantin : Service General Requirements : and label with

PRINTED 01/13/2010 FORM APPROVED

Cali ornia Deoartment of Public Health

STA TEr,IENT OF DEFICIENCIES AND PLAN OF CORRECTiON

(x 1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER

CA140000034

(X2) MUL TIPLE CONSTRUCTION

A BUILDI,'JG B WING _

(X3) DATE SURVEY COMPLETED

C 10/14/2009

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE

ALAMEDA COUNTY MEDICAL CENTER 1411E31STST OAKLAND, CA 94602

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES 10 PROVIDER'S PLAN OF CORRECTION IXS)

PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETE

TAG REGULA TORY OR LSC IDENTIFYING INFORMATION) TAG CROSS·REFERENCED TO THE APPROPRIATE DATE

, DEFICIENCY)

E 000 Initial Comments

The following reflects the findings of the California Department of Public Health during the investigation of an entity reported incident.

ENTITY REPORTED INCIDENT NUMBER CAOO204680

Representing the Department , RN, HFEN and

, Pharmaceutical Consultant, II

The inspection was limited to the specific entity reported incident investigated and does not represent the findings of a full inspection of the facility

E 264 T22 DIV5 CH1 ART3-70213(a) Nursing Service Policies and Procedures.

(a) Written policies and procedures for patient care shall be developed, maintained and implemented by the nursing service.

This Statute is not met as evidenced by:

E 474 T22 DIV5 CH1 ART3-70263(c) Pharmaceutical Service General Requirements

(c) A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established The committee shall consist of at least one physician, one pharmacist, the director of nursing service or her representative and the administrator or his representative.

I

I E 000

I

I I E 264

I

I E 474

I , I I

I RECEIVED FEB 01 2010

I Licensing & Certificationi East Bay District Office I ! I

I I E 264 T22 DJV5 CHI ART3-70213(a)

Nursing Services Policies and Procedures

I

I E 474 T22 DJV5 CHI ART3-70263(c) Pharmaceutical Service General Requirements E 475 T22 DJV5 CHI ART3-70263(c)(I) Pharmaceutical Service General Requirement E 483 T22 DJV5 CHI ART3-70263(g) Pharmaceutical Service General Requirement E .J85 T22 DIV5 CHI ART3-70263(g)(2)

I Pharmaceutical Service General

I Requirements The Hospital failed to ensure policies and procedures related to medication distribution

I and medication administration were

I implemented and the Dilantin was administered as ordered. Patient received

I

I one gram of DiJantin IV? (intravenous push) within five minutes that should have been given slowly over an hour as ordered by the physician. The medication error resulted in

STATE FOPld ~,10V011

TITLE

CEJ 0 n .


California Deoartment of Public Health

STA TEr-'lENT OF DEFICIENCIES AND PLAN OF CORRECTION


CA140000034

\X2) MUL TIPLE CONSTRUCTION

A BUILDING

B WING _

(X3) DA TE SURVEY COMPLETED

C 10/14/2009

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE, ZIP CODE


SUMMARY STATEMENT OF DEFICIENCIES PROVIDER'S PLAN OF CORRECTION

PREFIX iX4) 10 10 IXS)

.EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE cor-. PLE E ATEREGULATORY OR LSC IDENTIFYING INFOR1I.IATIONj CROSS·REFERENCED TO THE APPROPRIATE

DEFICIENCY) TAG TAG

E 474 Continued From page 1 E 474

This Statute is not met as evidenced by: the rapid deterioration and death of patient.

E 475

j I

T22 DIV5 CH 1 ART3-70263( c)( 1) I

Pharmaceutical Service General Requirements E 475

I Corrective Action: 1. All ICU RN staff were re-educated on

the Medication Administration policy I and procedures.

2. All rcu RN's were educated on

(1) The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementations of procedures. Policies shall be approved by the governing bOdy.j Procedures shall be approved by the . administration and medical staff where such is I:

appropriate.

Transcribing Medication physician orders.

I 3. All pharmacists were in-serviced to I provide drug, dosage route and rate of

administration when any nursing staff calls pharmacy requesting information regarding medications.

4, All rcu staff were re-educated regarding Dilantin, the indications the route dosage and rate of admi~istration for a loading dose.

1

5. Pharmacy added DiJantin to the High Risk Medications policy and re-educated the nursing staff regarding Dilanti~ and

This Statute is not met as evidenced by: High Risk medications. 6. All Dilantin was removed from ACMC

pyxis machines immediately upon notification of the event.

E 483 T22 DIV5 CH1 ART3-70263(g) Pharmaceutical E 483 7. Pharmacists will now mix all Dilantin

Service General Requirements and label with drug name, dose, route, and administration rate.

(g) No drugs shall be administered except by 8. Additional ICU competencies have been

licensed personnel authorized to administer developed specifically addressing high

drugs and upon the order of a person lawfully risk alert medications and medication

authorized to prescribe or furnish. This shall not I administration which will now require

preclude the administration of aerosol drugs by I' any RN working in lCU to take written

respiratory therapists. The order shall include the name of the drug, the dosage and the frequency I 9.

cognitive test. The electronic time of the scanned

of administration, the route of administration, if pharmacy orders on this patient were

other than oral, and the date, time and signature I reviewed to identify any process and

of the prescriber or furnisher. Orders for drugs system errors. ICU orders were scanned should be written or transmitted by the prescriber : to pharmacy at 1446 and medication was or furnisher. Verbal orders for drugs shall be

I

LicenSing and Certification DIVISion

STATE FORM 66'J9 MOV011 It conI I, ;;on s~eet 2 of 7


California Department of Public Health

STATEMENT OF DEFICIENCIES \X 1) PROVIDERISUPPLIER/C L1A IX2) MUL TIPLE CONSTRUCTION \X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER COi",1PLETED

A BUILDING

B WING _ C CA140000034 10/14/2009

STREET ADDRESS. CITY STATE. ZIP CODE

1411 E 31ST ST

NAME OF PROVIDER OR SUPPLIER

ALAMEDA COUNTY MEDICAL CENTER OAKLAND, CA 94602

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES 10 PROVIDERS PLAN OF CORRECTION (XSI


TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE

DEFICiENCY)

E 483 Continued From page 2 I E 483 administered at 2155. [t was identified that the order written at 1400 was not

given only by a person lawfully authorized to reviewed by pharmacy since Dilantin prescribe or furnish and shall be recorded was in the Pyxis and assumed bypromptly in the patient's medical record, noting phannacy that Dilantin had already been the name of the person giving the verbal order and the signature of the individual receiving the order. The prescriber or furnisher shall countersign the order within 48 hours.

This Statute is not met as evidenced by:

E 485

Pharmaceutical Service General Requirements E 485 T22 DIV5 CH1 ART3-70263(g)(2)

(2) Medications and treatments shall be administered as ordered.

This Statute is not met as evidenced by: Based on staff interview and record reviews the hospital failed to ensure policies and proced'ures related to medication distribution and medication I administration were Implemented and the Dilantin I was administered as ordered. Patient 14 received I onegr~m of Dilantin IVP (intravenous push) I within five minutes that should have been given ' slowly over an hour as ordered by the physician. The medication error resulted in the rapid deterioration and death of Patient 14.

administered. This has been corrected by removing all Dilantin from the Pyxis and requiring phannacy to prepare the drug for administration.

10. Nursing and Phannacy developed a proactive committee to review and flow the medication process to identify process/system issues that would put patients at risk for medication event.

II. ICU will implement 12 hour chart checks for nursing to check all MARs' for complete drug infonnation which includes drug, dose, route, and rate of administration and compare the MAR to the physician's orders.

12. The RN who administered the drug was placed on Do Not Return, the registry who employees the RN was notified the CDPH, The Joint Commission, and ;he California Board of Nursing was also notified of the event.

Completion Date: 1. 10/14/09 2. 10/14/09 3. 10/14/09 4. 10/14/09

I 5. 10/14/09 6. 10/14/09Findings: 7. 10/14/09I 8. 12/31/09The Discharge Summary dated 10/14/09 showed I 9. 10/14/09that the hospital admitted Patient 14 on 10/05109 10. 10/15/09for sudden shortness of breath and chest pain. I J 1. 10114/09Patient 14 had a history of hypertension and end

, 12. 1011 5/09stage renal disease. Patient 14 received dialysis I (process to remove chemicals and wastes from I

Licensing and Certlficallon Division

STATE FORM rvlOVQ11 II COnllllLJdllOI1 sheel 3 JI 7t39


California Deoartment of Public Health

S TA TE~.lENT OF DEFICIENCIES AND PLAN OF CORRECTION


CA140000034

(X2) MULTIPLE CONSTRUCTION

A BUILDING

B WING _

\X3) DATE SURVEY COMPLETED

C 10/14/2009

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE


(X4) 10 SUM/,1ARY STATEMENT OF DEFICIENCIES 10 PROVIDER'S PLAN OF CORRECTION IXS)


TAG REGULATORY OR LSC IDENTIFYING INFORMA TION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE

DEFICIENCY)

E 485 E 485 Continued From page 3 I

the blood through a machine when the kidneys no I ! :\1onitoring:

I. Nursing will review 30 charts per m nth longer function) three times a week on Mondays, I: to ensure that MAR's match the Wednesdays and Fridays. physician orders and have the drug,

The Progress Notes dated 1017109 showed that I dosage, route and rate of administration for every medication.

while having hemodialysis, Patient 14 had 2. Daily nursing will review, during the 12 seizures, high blood pressure and developed hour chart check, all MARs for pulmonary edema (lung congestion) that required completeness with drug, dose, route, and intubation (insertion of breathing tube and rate of administration. connected to a respirator). Patient 14 was transferred to the intensive care unit at 240 p.m I 3. The Director of Pharmacy will randomly

observe pharmacy providing drug information to ensure all elements, drug,

The physician's orders dated 10/7/09 at 2 pm dose, route, and rate of administration. included a physician's order that specifically stated to check the patient's dilantin level first and Persons Responsible: to, "give 1 gm (gram) Dilantin over 1 hr (hour). IV Tina Bray, Director of Nursing (into the bloodstream through a vein access), I Gurpreet Johal, Director of Pharmacydon't push quickly." A Consultation Report dated 1017/08 at 3 p m. indicated that Patient 14 was,

I

! Linda Jenkins, CNE Bill Manns, COO

"Currently hemodynamically (pertains to blood Jeanette Cotanche, CQO circulation) stable."

Review of the Medication Record showed a handwritten transcription of the order for Dilantin as, "Dilantin 1000 mg load." Dilantin was initialed and signed by RN Z as given on 10/7/09 at 9:55 p.m RN Z administered the Dilantin loading dose within five minutes IVP (manually and directly into the bloodstream through a vein access)

The Progress Record dated 10/7/09 at 1040 pm. showed that at 1001 p.m., (six minutes after Dilantin was given), Code Blue was called in the intensive care unit because Patient 14 had bradycardia (heart rate less than 60 per minute) with PEA (pulse less electrical activity of the heart), The resuscitation efforts failed. An ultrasound of Patient 14's heart taken at the bedside confirmed that Patient 14 did not have a

LtcenSJr1Q and Cerilflcallon DIVISion

STATE FORM


California Oepar ment of Public Health

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X 11 PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER

CA140000034

(X2) MUL TIPLE CONSTRUCTION

A BUILDING

B WING _

(X3) DATE SURVEY COMPLETED

C 10/14/2009

NAME OF PROVIDER OR SUPPliER STREET ADDRESS. CITY. STATE. ZIP CODE

ALAMEDA COUNTY MEDICAL CENTER 1411 E 31ST ST OAKLAND, CA 94602

(X4) 10 PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

10 PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE

CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY)

C ,X5)

MPlE r::o DATE

E 485 I

Continued From page 4 I E 485

cardiac tamponade (compression of the heart I resulting from the accumulation of fluid within the I heart sac) and that there was no heart activity. Patient 14 died at 1024 pm II

Review of the hospital's written Medication Administration policy and procedure, revised on II

2/09 showed that its purpose was to ensure safe administration of medications to patients. Medications are administered to patients by licensed and approved personnel that included registered nurses. The Medication Administration policy and procedure showed that all inpatient orders will be scanned to the Inpatient Pharmacy, reviewed by a pharmacist and entered into the Pharmacy Computer System that would generate a patient specific label. Pharmacy would prepare, check and match the medication with the I associated label in preparation for delivery. The policy indicated that it would be the responsibility of the nurse to review the patient specific label for accuracy.

The Medication Administration procedure required that before the administration of a medication, the registered nurse who would administer the medication would verify the medication based on the medication order and product label. The registered nurse would verify and be familiar that the medication be administered at the right dose, correct route and rate of administration.

Review of a memorandum dated 10/8/09 showed that RN Z pushed one gram of Dilantin over five minutes, and the cardiac strips clearly indicate rhythm changes at that time. RN Z had said that she clarified with the pharmacist how to give the I Oilantin and was told to "push" Dilantin.

Licensing and Cert,flC3lion DIVIsion STATE FORM MOV011 If continuation sheel 5 of 7


California Department of Public Health

STA TEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X 1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER'

CA140000034

iX2) MUL TIPLE CONS TRUCTION

A BUILDING

B WING _

IX3) DA TE SURVEY COMPLETED

C 10/14/2009

NAME OF PROVIDER OR SUPPLIER

ALAMEDA COUNTY MEDICAL CENTER

STREET ADDRESS. CITY STATE. ZIP CODE

1411 E31STST OAKLAND, CA 94602

(X4) 10 PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

10 PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE

CROSS·REFERENCED TO THE APPROPRIATE DEFICIENCY)

'X5) CC.\-IPLc.,; to

DAn:

E 485 Continued From page 5

The Lexi-Comp's Drug Information Handbook, 2009- 2010 18th Edition listed that Dilantin is a drug to manage and prevent seizures. The warning and precautions with its use in IV form include hypotension and bradycardia, The adverse effects included, but not limited to hypotension, bradycardia, cardiac arrhythmias and cardiovascular collapse (especially with rapid IV use) The maximum rate of administration is 50 I mg per minute. All loading doses of Dilantin should be administered in IVPB in saline,

During an interview on 10/14/09 at 1027 a,m. RN Z said, she called the pharmacy on 10/7/09 and requested the pharmacy to mix Dilantin, According to RN Z, the pharmacist instructed her to get four ampoules of Dilantin 250 mg from the Pyxis (a medication distribution system) and give I the medication IV, without any recommendation on how to give it RN Z said, "It shouldn't have happened, I shouldn't have listened to the pharmacist, and it didn't sound right to give four vials IV push, I should have refused," RN Z failed to review and follow the physician's order to give Dilantin over an hour, RN Z failed to recognize that the maximum rate of IV administration of dilantin was 50 mg per minute,

During an interview on 10/14/09 at 12:10 p.m., Pharmacist A acknOWledged she received a telephone call from RN Z and instructed RN Z to mix four ampoules of Dilantin 250 mg in a 250 ml bag of saline and use a 22 micron filter when administering the Dilantin. Pharmacist A failed to indicate the rate of administration she had instructed RN Z to give the total amount of Dilantin 1000 mg,

During an interview on 11/19/09 at 9:30 am, the Director of Pharmacy acknowledged that Dilantin I

E 485

LicenS1I1Q 3nd CertificatIon DIVISIon

STATE FORM MOV011 It continuation sheel '3 of 7


CaliFornia Oeoartment of Public Health

STATEMENT OF DEFICIENCIES (x 1) PROVIDER/SUPPLIER/CLIA \X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED

A BUILDING B WING _ C

CA140000034 10/14/2009 NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE

1411 E31STST ALAMEDA COUNTY MEDICAL CENTER OAKLAND, CA 94602

(X4) 10 SU,"'MARY STATEMENT OF DEFICIENCIt::S 10 PROVIDER'S PLAN OF CORRECTION (;(5)


TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS·REFERENCED TO THE APPROPRIATE o TE

DEFICIENCY)

E 485 Continued From page 6 E 485 1I order for Patient 14 was not reviewed in advance of administration as required by the current policy I I and procedure on Medication Administration. There was no evidence that the pharmacy received and reviewed the scanned physician's order For Dilantin written on 10/7/09 at 2 p.rn The nurse administered Oilantin 1000 mg on 10/7/09 at 955 pm within five minutes (rather than an hour). The hospital staff had approximately over seven hours to correctly process the Dilantin order to ensure the safe administration of the drug to Patient 14 and prevent the medication error.

The facility's failure to ensure its medication distribution and administration policies were followed is a deficiency that has caused, or is likely to cause, serious injury or death to the patient, and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code section 1280 1(c).

LicenSing and Certification DIvIsion

STATE FORM MOV011 If conllnualion sneel 7 of 7

Documents

I E - CDPH Home Document Libr… · E 483 . T22 DIV5 CH1 ART3-70263(g) Pharmaceutical E 483 : 7. Pharmacists will now mix all Dilantin : Service General Requirements : and label with